Pharmacy Assurance coordinates a standardised single technical pharmacy review for eligible studies across the UK. The completed review can be used by all participating NHS/HSC sites across the UK to support local capacity and capability assessments and study set up in their pharmacy departments.

What are the benefits of Pharmacy Assurance?

For Sponsors/Applicants

  • fewer duplicated queries from multiple sites
  • guidance on the information requirements for the pharmacy review included in the Local Information Pack (LIP) wherever possible, which can lead to sites agreeing to participate sooner and help to streamline site set up.

Please note that inclusion in the LIP is only possible if an application to Pharmacy Assurance is submitted by or on the day of e-submission.


For Pharmacy Departments/Participating Sites

  • an assured level of detail thanks to comprehensive and standardised information in the pharmacy review form
  • information at the right time to support capacity and capability assessments
  • reduction in the number of queries during capacity and capability assessments and during study set up

Feedback on the Process

"...impressed with the timelines in which this study was reviewed."

Commercial Sponsor

"Allows the information to be efficiently shared with the sites... making the set up process quicker"

NHS Sponsor

"... the form was really helpful, it enabled us to quickly assess capacity and capability as it had really detailed information that we may not otherwise have received. It was also useful to refer back to when setting the study up"

NHS Site

Can I submit for Pharmacy Assurance?

Pharmacy Assurance is currently going through a phased roll-out, but we expect that all eligible multi-centre studies will be submitted. Single site studies are not eligible to be submitted.

Pharmacy Assurance will be a component of HRA and HCRW Approval once the roll-out is completed.

Detailed submission guidance is available on the IRAS website, but our Applying for Pharmacy Assurance page provides an overview for those going through the process and clarifies which studies are currently eligible to be submitted.

Performance metrics for Pharmacy Assurance

We regularly publish updates on our performance in relation to Pharmacy Assurance. The below is the latest performance data for April to June 2021..

Studies are currently progressing through Pharmacy Assurance in 22 calendar days. This time is measured from the point of submission by the study sponsor, to completed review and issuing of Pharmacy Assurance. This data is excluding queries.

PA Average Review Time Apr-Jun 2021.png
Figure 1 shows the average HRA review times for HRA-managed Pharmacy Assurance submissions from January to March 2021

Feedback

We value all feedback, if you would like to tell us about your experience of using Pharmacy Assurance please contact us by e-mailing pharmacy.assurance@hra.nhs.uk.

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